OMEGAVEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMEGAVEN (OMEGAVEN).
Omega-3-acid ethyl esters (OMEGAVEN) are a mixture of ethyl esters of omega-3 fatty acids, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). They reduce hepatic very-low-density lipoprotein (VLDL) synthesis by inhibiting diacylglycerol acyltransferase (DGAT) and increasing peroxisomal beta-oxidation. They also increase fatty acid oxidation and reduce lipogenesis in the liver, leading to decreased triglyceride levels.
| Metabolism | Omega-3-acid ethyl esters are hydrolyzed by pancreatic lipases in the gastrointestinal tract to form free fatty acids (EPA and DHA), which are then absorbed. They are metabolized primarily via beta-oxidation and are not significantly metabolized by cytochrome P450 enzymes. |
| Excretion | Omega-3 fatty acids from OMEGAVEN are primarily metabolized via beta-oxidation; minimal renal excretion (<5% unchanged). Biliary/fecal excretion accounts for the majority of elimination as metabolites. |
| Half-life | The terminal elimination half-life of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is approximately 5-10 days, reflecting slow turnover in plasma phospholipids and incorporation into cell membranes. |
| Protein binding | Omega-3 fatty acids are extensively bound to albumin and lipoproteins, with >99% protein binding. |
| Volume of Distribution | Apparent volume of distribution is approximately 0.1-0.2 L/kg, consistent with distribution primarily in plasma and extracellular fluid, with incorporation into cell membranes over time. |
| Bioavailability | Oral bioavailability of omega-3-acid ethyl esters is approximately 20-30% due to incomplete absorption and first-pass metabolism; absorption is enhanced when taken with dietary fat. |
| Onset of Action | Clinical effects (e.g., reduction in serum triglycerides) are typically observed after 2-4 weeks of daily oral administration; maximal effects may take 6-12 weeks. |
| Duration of Action | Duration of action persists for several weeks after discontinuation; triglyceride levels return to baseline over 4-6 weeks due to gradual depletion of tissue stores. |
Continuous IV infusion of 0.5-1.0 g/kg/day (as total lipid calories) not to exceed 2.5 g/kg/day, typically administered over 12-24 hours. Maximum infusion rate: 0.1 g/kg/hour.
| Dosage form | EMULSION |
| Renal impairment | No specific dose adjustment required for renal impairment. Monitor serum triglycerides closely in patients with renal dysfunction. |
| Liver impairment | Contraindicated in severe hepatic failure (Child-Pugh class C). Use with caution in Child-Pugh class A or B; consider reducing dose by 50% and monitor lipid clearance. |
| Pediatric use | For preterm and term infants: 0.5-2.0 g/kg/day (as total lipid calories) by continuous IV infusion. Maximum 3 g/kg/day in neonates. Use weight-based dosing with close monitoring of triglycerides. |
| Geriatric use | No specific dose adjustment required, but monitor triglycerides due to potential age-related changes in lipid metabolism. Use lower end of dosing range (0.5-1 g/kg/day) in frail elderly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMEGAVEN (OMEGAVEN).
| Breastfeeding | Omega-3-acid ethyl esters (component of Omegaven) are present in breast milk; M/P ratio not established. Caution and monitor infant for adverse effects. |
| Teratogenic Risk | No evidence of teratogenicity in animals; no adequate controlled studies in pregnant women. Use only if clearly needed. Avoid during first trimester unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity (e.g., anaphylaxis) to fish or shellfish","Severe liver disease (Child-Pugh C)"]
| Precautions | ["May increase LDL-C levels in some patients; monitor lipid panel periodically","Risk of atrial fibrillation or flutter, particularly in patients with cardiovascular disease or at high risk; monitor for arrhythmias","Potential for allergic reactions in patients with fish or shellfish allergy","May prolong bleeding time; monitor in patients on anticoagulants or with bleeding disorders","Not recommended in patients with liver impairment (Child-Pugh B and C)"] |
Loading safety data…
| Monitor maternal coagulation parameters (INR, bleeding time) and fetal growth (ultrasound) if used for prolonged periods. Check for signs of bleeding in neonate. |
| Fertility Effects | No known negative effects on fertility; animal studies show no impairment. In vitro data suggest possible improvement of oocyte quality. |